Clinical Study to Evaluate Treatment With ORACEA® for Geographic Atrophy (TOGA)

Overview

This is a prospective, randomized study to evaluate the efficacy and safety of ORACEA® in the treatment of geographic atrophy due to dry age-related macular degeneration (AMD).

Full Title of Study: “A Randomized, Double Blind, Placebo Controlled Study Evaluating ORACEA® in Subjects With Geographic Atrophy Secondary to Non-Exudative Age-Related Macular Degeneration”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2020

Detailed Description

Eligible participants will complete a 6-month Observation Phase, followed by a 24-month Treatment Phase, followed by an End of Study Visit. Eligible participants will be randomized at Month 6 in a 1:1 ratio to either ORACEA (40 mg doxycycline) or placebo capsule to be taken once-daily for 24 months. Over the course of the 31-month study, a total of 9 clinic visits and 3 telephone calls are required.

Interventions

  • Drug: ORACEA®
    • ORACEA® (40mg doxycycline) capsule daily for 24 months
  • Drug: Placebo
    • Placebo capsule daily for 24 months

Arms, Groups and Cohorts

  • Experimental: ORACEA®
    • 40mg doxycycline
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Rate of enlargement in area of geographic atrophy in the study eye during the treatment period.
    • Time Frame: Month 6 and Month 30

Secondary Measures

  • Change in Best Corrected Visual Acuity (BCVA)
    • Time Frame: Month 6 and Month 30

Participating in This Clinical Trial

Inclusion Criteria

  • Male or female, age >/=55 years
  • Best corrected visual acuity of 20/20 – 20/400 in the study eye
  • Best corrected visual acuity of hand motion or better in the non-study eye
  • Clinical diagnosis of geographic atrophy secondary to non-exudative age-related macular degeneration in at least one eye (study eye)
  • Geographic atrophy lesions of ≥ 0.5 and ≤ 7.0 MPS disc areas

Exclusion Criteria

  • History of or active presence of choroidal neovascularization secondary to exudative age-related macular degeneration in the study eye
  • History of or active presence of choroidal neovascularization secondary to exudative age-related macular degeneration in the non-study eye requiring any treatment within 12 months prior to Day 0 or expected to require treatment for the duration of the study
  • Prior treatment for non-exudative age-related macular degeneration
  • Current or previous history of treatment of the study eye with any tetracycline derivative for any ocular condition.
  • History of vitreoretinal surgery, corneal transplant, or laser photocoagulation in the study eye
  • Any intraocular or periocular surgery within 90 days prior to Day 0 in the study eye.
  • History of any hypersensitivity to tetracycline components
  • Use of a tetracycline derivative therapy for a concurrent systemic or ocular disorder within 90 days of Day 0
  • History of sensitivity to the sun

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Paul Yates, MD, PhD
  • Collaborator
    • MEDARVA Foundation
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Paul Yates, MD, PhD, Associate Professor of Ophthalmology – University of Virginia
  • Overall Official(s)
    • Paul A Yates, MD, PhD, Principal Investigator, University of Virginia

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